Method for forming through a guard an implantation space in the human spine

• US 7,115,128 B2
• Filed: 10/15/2003
• Issued: 10/03/2006
• Est. Priority Date: 06/13/1988
• Status: Expired due to Fees

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Michelson, Gary Karlin
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US10/685,776
• Publication Number:
  US 20040078039A1
• Time in Patent Office: 1,084 Days
• Field of Search: 606 60- 61, 623/16.1, 623/17.1, 623/17.2
• US Class Current: 606/279
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/8888 at its central region
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30774 internally-threaded
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/3085 with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/448 comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2002/4619 : for extraction
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0069 : cylindrical

Abstract

An artificial spinal implant is disclosed which when placed between two adjacent vertebrae directly participates and is incorporated in the ensuing fusion. Instrumentation and procedure is also disclosed.

Claims

1. A method for preparing an implantation space in a vertebra of the human spine, the method comprising the steps of:

positioning one end of a hollow guard in contact with at least one vertebra, the one end of the guard having a height;

placing an instrument into the hollow guard, the instrument having a longitudinal axis;

moving the instrument along the longitudinal axis of the instrument to form an opening into the vertebra; and

inserting, through the hollow guard and into the opening, an implantation material suitable for human implantation of sufficient strength to support the bone of the vertebra, the implantation material rigidly stabilizing the implantation space occupied by the implantation material, the method being performed without altering the height of the one end of the guard between the forming step and the inserting step.

2. The method of claim 1, wherein the moving step includes the sub-steps of removing the instrument from the guard;

and inserting a second instrument through the guard to enlarge the opening.

3. The method of claim 1, wherein the moving step includes the sub-step of drilling the vertebra.

4. The method of claim 1, wherein the moving step includes inserting a drill into the guard to access the vertebra with the drill.

5. The method of claim 1, wherein the positioning step includes the step of positioning at least a portion of the hollow guard in the vertebra.

6. The method of claim 1, wherein the inserting step includes inserting the implantation material comprising a fusion-promoting substance.

7. The method of claim 1, further comprising the step of inserting an inner sleeve within the guard.

8. The method of claim 1, wherein the method is performed without removing the hollow guard between the positioning step and the inserting step.

9. The method of claim 1, wherein the inserting step includes the sub-step of inserting an implant having at least upper and lower portions that are arcuate along at least a portion of the length of the implant.

10. The method of claim 9, wherein the inserting step includes the sub-step of inserting the implant further comprising a hollow interior between the upper and lower arcuate portions of the implant for holding bone growth promoting material, each of the upper and lower portions of the implant having at least one opening in communication with the hollow interior to permit bone from the vertebra to grow through the implant.

11. The method of claim 10, further comprising the step of loading the hollow interior of the implant with fusion promoting substances.

12. The method of claim 11, wherein the loading step includes the sub-step of loading the hollow interior of the implant with bone.

13. The method of claim 1, wherein the inserting step includes inserting the implantation material that comprises at least in part of an implantation material other than bone.

14. The method of claim 1, wherein the inserting step includes the sub-step of inserting an implant having the upper and lower portions having at least one protrusion on the upper and lower portions for engaging the vertebra.

15. The method of claim 14, wherein the protrusion is at least a portion of a thread.

16. The method of claim 1, wherein the inserting step includes the sub-step of inserting an implant having a hollow interior and at least one of an insertion end and a trailing end that is open and adapted for loading bone growth promoting substances into the hollow interior.

17. The method of claim 16, further comprising the step of engaging an end cap for closing the open end of the implant.

18. The method of claim 1, wherein the inserting step includes the sub-step of inserting an implant having an insertion end and a trailing end, the trailing end being adapted to cooperatively engage a driver for inserting the implant through the hollow guard and into the opening.

19. The method of claim 1, wherein the positioning step includes the step of engaging the one end of the hollow guard to the vertebra.

20. The method of claim 1, wherein the positioning step includes the sub-step of positioning the guard that is a tubular sleeve that is at least in part hollow.

21. The method of claim 1, wherein the positioning step includes the sub-step of positioning the guard having a length defined by a distal portion and a proximal portion forming the length, the guard having a substantially uniform cross section along its distal portion.

22. The method of claim 1, wherein the positioning step includes the sub-step of positioning the guard having a substantially uniform cross section along its length.

23. The method of claim 22, wherein the one end of the guard has a cross sectional configuration substantially the same as the substantially uniform cross section of the guard.

24. The method of claim 1, wherein the positioning step includes the sub-step of positioning the guard having the one end having a circumference that is uninterrupted and constant.

25. The method of claim 24, further comprising projections extending from the uninterrupted and constant circumference of the one end of the guard for engaging the spine.

26. The method of claim 1, wherein the forming step includes the sub-step of forming an opening having arcuate portions.

27. The method of claim 1, wherein the forming step includes the sub-step of forming an opening that is generally cylindrical.

28. The method of claim 1, wherein the positioning step includes the step of positioning the one end of the guard in contact with the vertebra of the posterior lumbar spine.

29. The method of claim 1, further comprising the step of placing pressed biomaterial into the implantation space.

30. The method of claim 1, wherein the material is injectable.

31. The method of claim 30, further comprising the step of injecting the material that is inserted into the implantation space.

32. The method of claim 1, further comprising the step of providing the material to be inserted in the form of an elongated portion having a length and a maximum cross sectional dimension perpendicular to the length.

33. The method of claim 32, further comprising the step of pressing the provided material prior to the step of inserting the material into the implantation space.

34. The method of claim 32, further comprising the step of pressing the provided material to change the shape of the elongated portion to have a lesser length and a greater maximum cross sectional dimension perpendicular to the length.

35. The method of claim 32, wherein the maximum cross sectional dimension perpendicular to the length is round in cross section.

36. The method of claim 32, wherein the length of the elongated portion is at least 32 millimeters.

37. The method of claim 1, wherein the moving step includes the step of rotating the instrument about the longitudinal axis of the instrument to form the opening into the vertebra.

38. A method for preparing a vertebra of the human spine, comprising the steps of:

positioning one end of a guard having a passage onto the vertebra with the passage of the guard overlapping a portion of the vertebra, the one end of the guard having a height;

forming, through the passage of the guard, an opening at least in part into the portion of the vertebra overlapped by the passage of the guard; and

inserting a biomaterial through the passage of the guard and into the opening formed in the vertebra, the method being performed without altering the height of the one end of the guard between the forming step and the inserting step.

39. The method of claim 38, wherein the forming step includes the sub-step of inserting an instrument through the guard to access the bone of the vertebra.

40. The method of claim 38, wherein the forming step includes the sub-step of milling the vertebra.

41. The method of claim 38, wherein the forming step includes the sub-step of drilling the vertebra.

42. The method of claim 38, further comprising the step of inserting a drill into the guard to access the vertebra with the drill.

43. The method of claim 38, wherein the biomaterial comprises a fusion-promoting substance.

44. The method of claim 38, wherein the biomaterial comprises bone.

45. The method of claim 38, wherein the positioning step includes the step of positioning at least a portion of the guard in the vertebra.

46. The method of claim 38, further comprising the step of inserting an inner sleeve within the guard.

47. The method of claim 38, wherein the method is performed without removing the guard between the positioning step and the inserting step.

48. The method of claim 38, wherein the forming step includes the sub-step of forming an opening having arcuate portions.

49. The method of claim 38, wherein the forming step includes the sub-step of forming an opening that is generally cylindrical.

50. The method of claim 38, wherein the positioning step includes the step of engaging the one end of the hollow guard to the vertebra.

51. The method of claim 38, wherein the positioning step includes the sub-step of positioning the guard having projections projecting distally from the one end for penetrably engaging the posterior surface of the vertebra.

52. The method of claim 38, wherein the positioning step includes the sub-step of positioning the guard that is a tubular sleeve that is at least in part hollow.

53. The method of claim 38, wherein the positioning step includes the sub-step of positioning the guard having a length defined by a distal portion and a proximal portion forming the length, the guard having a substantially uniform cross section along its distal portion.

54. The method of claim 38, wherein the positioning step includes the sub-step of positioning the guard having a substantially uniform cross section along its length.

55. The method of claim 54, wherein the one end of the guard has a cross sectional configuration substantially the same as the substantially uniform cross section of the guard.

56. The method of claim 38, wherein the positioning step includes the sub-step of positioning the guard having the one end having a circumference that is uninterrupted and constant.

57. The method of claim 56, further comprising projections extending from the uninterrupted and constant circumference of the one end of the guard for engaging the spine.

58. The method of claim 38, wherein the positioning step includes the step of positioning the one end of the guard in contact with the vertebra of the posterior lumbar spine.

59. The method of claim 38, wherein the inserting step includes placing compressed biomaterial into the opening.

60. The method of claim 38, wherein the biomaterial is injectable.

61. The method of claim 60, further comprising the step of injecting the biomaterial that is inserted into the opening.

62. The method of claim 38, further comprising the step of providing the biomaterial to be inserted in the form of an elongated portion having a length and a maximum cross sectional dimension perpendicular to the length.

63. The method of claim 62, further comprising the step of pressing the provided biomaterial prior to the step of inserting the biomaterial into the opening.

64. The method of claim 62, further comprising the step of pressing the provided biomaterial to change the shape of the elongated portion to have a lesser length and a greater maximum cross sectional dimension perpendicular to the length.

65. The method of claim 62, wherein the maximum cross sectional dimension perpendicular to the length is round in cross section.

66. The method of claim 62, wherein the length of the elongated portion is at least 32 millimeters.

67. The method of claim 39, wherein the sub-step of inserting an instrument includes the sub-step of rotating the instrument about a longitudinal axis of the instrument to form the opening into the vertebra.

68. A method for internal stabilization of at least a portion of the human spine, the method comprising the steps of:

engaging one end of a hollow tubular member with at least one vertebra of the spine, the one end of the tubular member having a height;

providing a first instrument that extends through the tubular member and beyond the one end of the tubular member;

forming an opening into the vertebra with the first instrument;

removing the first instrument from the tubular member;

inserting a second instrument through the tubular member and into the opening;

enlarging the opening with the second instrument; and

inserting, through the hollow tubular member and into the enlarged opening, a material suitable for human implantation of sufficient strength to support the bone of the vertebra, the material rigidly stabilizing at least a portion of the human spine, the method being performed without removing the hollow tubular member from the vertebra between the engaging step and the inserting material step.

69. The method of claim 68, wherein the method is performed without altering the height of the one end of the tubular member between the providing step and the inserting material step.

70. The method of claim 68, wherein the inserting step further comprises inserting a material inserter having a distal end into the hollow tubular member, the material inserter having the material extending beyond the distal end of the material inserter.

71. The method of claim 70, further comprising the step of positioning the material into the enlarged opening beyond the one end of the tubular member.

72. The method of claim 68, further comprising the steps of inserting the first instrument into the tubular member and then extending the first instrument beyond the one end of the tubular member.

73. The method of claim 68, wherein the providing step includes the sub-step of inserting a drill.

74. The method of claim 68, wherein the inserting material step includes inserting the material comprising a biomaterial into the opening through the hollow tubular member.

75. The method of claim 68, wherein the inserting material step includes inserting the material comprising a fusion-promoting substance.

76. The method of claim 68, further comprising the step of inserting an inner sleeve within the tubular member.

77. The method of claim 68, wherein the inserting material step includes the sub-step of inserting an implant having at least upper and lower portions that are arcuate along at least a portion of the length of the implant.

78. The method of claim 77, wherein the inserting material step includes the sub-step of inserting the implant further comprising a hollow interior between the upper and lower arcuate portions of the implant for holding bone growth promoting material, each of the upper and lower portions of the implant having at least one opening in communication with the hollow interior to permit bone from the vertebra to grow through the implant.

79. The method of claim 78, further comprising the step of loading the hollow interior of the implant with fusion promoting substances.

80. The method of claim 79, wherein the loading step includes the sub-step of loading the hollow interior of the implant with bone.

81. The method of claim 68, wherein the inserting material step includes inserting the material that comprises at least in part of a material other than bone.

82. The method of claim 68, wherein the inserting material step includes the sub-step of inserting an implant having the upper and lower portions having at least one protrusion on the upper and lower portions for engaging the vertebra.

83. The method of claim 82, wherein the protrusion is at least a portion of a thread.

84. The method of claim 68, wherein the inserting material step includes the sub-step of inserting an implant having a hollow interior and at least one of an insertion end and a trailing end that is open and adapted for loading bone growth promoting substances into the hollow interior.

85. The method of claim 84, further comprising the step of engaging an end cap for closing the open end of the implant.

86. The method of claim 68, wherein the inserting material step includes the sub-step of inserting an implant having an insertion end and a trailing end, the trailing end being adapted to cooperatively engage a driver for inserting the implant through the tubular member and into the opening.

87. The method of claim 68, wherein the engaging step includes the step of positioning at least a portion of the tubular member in the vertebra.

88. The method of claim 68, wherein the engaging step includes the sub-step of engaging the tubular member having a length defined by a distal portion and a proximal portion forming the length, the tubular member having a substantially uniform cross section along its distal portion.

89. The method of claim 68, wherein the engaging step includes the sub-step of engaging the tubular member having a substantially uniform cross section along its length.

90. The method of claim 89, wherein the one end of the tubular member has a cross sectional configuration substantially the same as the substantially uniform cross section of the tubular member.

91. The method of claim 68, wherein the engaging step includes the sub-step of engaging the tubular member having the one end having a circumference that is uninterrupted and constant.

92. The method of claim 91, further comprising projections extending from the uninterrupted and constant circumference of the one end of the tubular member for engaging the spine.

93. The method of claim 68, wherein the step of forming the opening with the first instrument includes the step of forming the opening having arcuate portions.

94. The method of claim 93, wherein the forming step includes the sub-step of forming an opening that is generally cylindrical.

95. The method of claim 68, wherein the engaging step includes the step of engaging the one end of the tubular member in contact with the vertebra of the posterior lumbar spine.

96. The method of claim 68, further comprising the step of placing pressed material into the enlarged opening.

97. The method of claim 68, wherein the material is injectable.

98. The method of claim 97, further comprising the step of injecting the material that is inserted into the enlarged opening.

99. The method of claim 68, further comprising the step of providing the material to be inserted in the form of an elongated portion having a length and a maximum cross sectional dimension perpendicular to the length.

100. The method of claim 99, further comprising the step of pressing the provided material prior to the step of inserting the material into the enlarged opening.

101. The method of claim 99, further comprising the step of pressing the provided material to change the shape of the elongated portion to have a lesser length and a greater maximum cross sectional dimension perpendicular to the length.

102. The method of claim 99, wherein the maximum cross sectional dimension perpendicular to the length is round in cross section.

103. The method of claim 99, wherein the length of the elongated portion is at least 32 millimeters.

104. The method of claim 68, wherein the forming step includes the step of rotating the first instrument about a longitudinal axis of the first instrument to form the opening into the vertebra.

105. The method of claim 68, wherein the enlarging step includes the step of rotating the second instrument about a longitudinal axis of the second instrument to enlarge the opening into the vertebra.

106. A method for internal stabilization of at least a portion of the human spine, the method comprising the steps of:

positioning one end of a hollow tubular member in contact with at least one vertebra of the spine, the one end of the tubular member having a height;

providing a first instrument that extends through the tubular member and beyond the one end of the tubular member;

forming an opening into the vertebra with the first instrument;

removing the first instrument from the tubular member;

inserting a second instrument through the tubular member and into the opening;

enlarging the opening with the second instrument;

removing the second instrument from the tubular member; and

inserting a material suitable for human implantation into the enlarged opening through the tubular member, the method being performed without removing the hollow tubular member from the vertebra between the positioning step and the inserting material step.

107. The method of claim 106, wherein the method is performed without altering the height of the one end of the tubular member between the providing step and the inserting material step.

108. The method of claim 106, wherein the inserting material step further comprises inserting a material inserter having a distal end into the hollow tubular member, the material inserter having the material extending beyond the distal end of the material inserter.

109. The method of claim 108, further comprising the step of positioning the material into the enlarged opening beyond the one end of the tubular member.

110. The method of claim 106, further comprising the steps of inserting the first instrument into the tubular member and then extending the first instrument beyond the one end of the tubular member.

111. The method of claim 106, wherein the providing step includes the sub-step of inserting a drill.

112. The method of claim 106, wherein the inserting material step includes inserting the material comprising a biomaterial into the opening through the hollow tubular member.

113. The method of claim 106, wherein the inserting material step includes inserting the material comprising a fusion-promoting substance.

114. The method of claim 106, further comprising the step of inserting an inner sleeve within the tubular member.

115. The method of claim 106, wherein the inserting material step includes the sub-step of inserting an implant having at least upper and lower portions that are arcuate along at least a portion of the length of the implant.

116. The method of claim 115, wherein the inserting material step includes the sub-step of inserting the implant further comprising a hollow interior between the upper and lower arcuate portions of the implant for holding bone growth promoting material, each of the upper and lower portions of the implant having at least one opening in communication with the hollow interior to permit bone from the vertebra to grow through the implant.

117. The method of claim 116, further comprising the step of loading the hollow interior of the implant with fusion promoting substances.

118. The method of claim 117, wherein the loading step includes the sub-step of loading the hollow interior of the implant with bone.

119. The method of claim 106, wherein the inserting material step includes inserting the material that comprises at least in part of a material other than bone.

120. The method of claim 106, wherein the inserting material step includes the sub-step of inserting an implant having the upper and lower portions having at least one protrusion on the upper and lower portions for engaging the vertebra.

121. The method of claim 120, wherein the protrusion is at least a portion of a thread.

122. The method of claim 106, wherein the inserting material step includes the sub-step of inserting an implant having a hollow interior and at least one of an insertion end and a trailing end that is open and adapted for loading bone growth promoting substances into the hollow interior.

123. The method of claim 122, further comprising the step of engaging an end cap for closing the open end of the implant.

124. The method of claim 106, wherein the inserting material step includes the sub-step of inserting an implant having an insertion end and a trailing end, the trailing end being adapted to cooperatively engage a driver for inserting the implant through the hollow tubular member and into the opening.

125. The method of claim 106, wherein the positioning step includes the step of engaging the one end of the hollow tubular member to the vertebra.

126. The method of claim 106, wherein the positioning step includes the sub-step of positioning the tubular member having a length defined by a distal portion and a proximal portion forming the length, the tubular member having a substantially uniform cross section along its distal portion.

127. The method of claim 106, wherein the positioning step includes the sub-step of positioning the tubular member having a substantially uniform cross section along its length.

128. The method of claim 127, wherein the one end of the tubular member has a cross sectional configuration substantially the same as the substantially uniform cross section of the tubular member.

129. The method of claim 106, wherein the positioning step includes the sub-step of positioning the tubular member having the one end having a circumference that is uninterrupted and constant.

130. The method of claim 129, further comprising projections extending from the uninterrupted and constant circumference of the one end of the tubular member for engaging the spine.

131. The method of claim 106, wherein the step of forming the opening with the first instrument includes the step of forming the opening having arcuate portions.

132. The method of claim 131, wherein the forming step includes the sub-step of forming an opening that is generally cylindrical.

133. The method of claim 106, wherein the positioning step includes the step of positioning the one end of the tubular member in contact with the vertebra of the posterior lumbar spine.

134. The method of claim 106, further comprising the step of placing pressed material into the enlarged opening.

135. The method of claim 106, wherein the material is injectable.

136. The method of claim 135, further comprising the step of injecting the material that is inserted into the enlarged opening.

137. The method of claim 106, further comprising the step of providing the material to be inserted in the form of an elongated portion having a length and a maximum cross sectional dimension perpendicular to the length.

138. The method of claim 137, further comprising the step of pressing the provided material prior to the step of inserting the material into the enlarged opening.

139. The method of claim 137, further comprising the step of pressing the provided material to change the shape of the elongated portion to have a lesser length and a greater maximum cross sectional dimension perpendicular to the length.

140. The method of claim 137, wherein the maximum cross sectional dimension perpendicular to the length is round in cross section.

141. The method of claim 137, wherein the length of the elongated portion is at least 32 millimeters.

142. The method of claim 106, wherein the forming step includes the step of rotating the first instrument about a longitudinal axis of the first instrument to form the opening into the vertebra.

143. The method of claim 106, wherein the enlarging step includes the step of rotating the second instrument about a longitudinal axis of the second instrument to enlarge the opening into the vertebra.